Regulatory Associate required for exciting new opportunity with medical device company in Central Belt of Scotland.Are you a science graduate with regulatory experience?Are you looking...
Regulatory Associate required for exciting new opportunity with medical device company in Central Belt of Scotland.
Are you a science graduate with regulatory experience?
Are you looking for a new challenging opportunity?
SRG is working with a leader in medical devices to recruit a Regulatory Associate to undertake a dynamic and challenging role to support regulatory compliance allowing products to be marketed globally. Reporting to the Director, you will be an enthusiastic and driven Regulatory Associate, with hands on experience in regulatory affairs within medical devices.
My client offers you a competitive salary and benefits package with the potential for development and skills improvement.
ROLE / DESCRIPTION
- Provide regulatory support and guidance to internal and external project teams
- Assure project is assessed and conducted to the relevant performance and regulatory standards thereby assuring the compliance, safety and efficiency of the product.
- Facilitate and organise external regulatory reviews, testing, approvals and reporting as required
- Accurate maintenance of technical files, standard technical documents, submissions and of all project based regulatory issues.
- Advising/training on regulatory procedures and documentation.
- Participation in cross functional project teams as Regulatory Affairs representative.
- Maintaining Software Specific Regulatory Documentation in line with guidelines.
- Generating Usability and Risk Analysis Documentation in line with standards.
- Review and development of protocols regulatory plans, design dossiers and change assessments.
- Degree in science, engineering or quality subject or equivalent work experiences.
- Practical experience of regulatory submissions and requirements within a medical device industry, experience in ISO9001 and ISO13485 is essential.
- You must have knowledge of FDA & MHRA systems and procedures as well as cGMP / Quality System Regulations and testing medical products to performance standards.
- Excellent presentation skills are required as is good computer skills.
SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing excellent temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
To apply for this position, please use the link provided. For more information regarding this position or any others, please contact Pamela.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, ethnicity, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Keywords: medical devices, ISO9001, ISO13485, FDA, MHRA, regulatory affairs, submissions, GMP, quality
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.